Clinical studies today are funded entirely by the pharma companies, keep that. Selling at cost of production would be something extra, for patients who want the drugs but aren't enrolled in an actual study. The company doesn't get solid data it can use for regulatory approval, so making them donate the drugs in that case seems excessive.
A downside would be that for drugs that don't cost much to produce, patients might be less willing to enroll in the studies, given the chance of getting a placebo. That could be handled by shutting down the informal access while the study is enrolled, for anyone who's eligible. I'm sure there are other wrinkles that would need to be considered too.
Put this way, this seems reasonable. Beyond cell therapy, I don't thin the cost of drug is the motivation for not making it more freely available. 'Misuse' leading to potential liability or unjustified bad outcomes, along with some regulatory burden seems like the issue.
Oh sick, so every time my company faces an economic downturn, I can shift huge amounts of workers to a program designed to sell unfinished drugs at cost! Like, it doesn’t even have to be viable, just start selling saline with coloring or something.
Unless it does have to be somewhat viable, which is… regulation.
I'm not against regulation in principle. In this case, full disclosure of exactly what's in the drug should definitely be required. People's doctors can make informed decisions after that.
Restricting this to patients who are otherwise out of options is probably also a good idea. Pancreatic cancer would certainly qualify.
